Professional Documents
Culture Documents
1. Introduction
The following document provides UNFPA’s technical requirements in the procurement of medical devices
(medical equipment, renewable medical supplies and medical kits excluding pharmaceuticals that might
accompany kits). It is intended to give to submitters all the necessary information for them to complete
understandable and homogenous dossiers.
From a general stand point, UNFPA’s technical requirements are based on the current standards and
regulations, for both manufacturer’s quality assurance and devices compliance.
The technical requirements also apply when the submitter is not the legal manufacturer 1(i.e.: a distribution
company). In this case, a letter from the manufacturer authorising the supplier will be required.
ELIGIBILITY: Only medical devices / equipment that have a CE mark and/or FDA 510k clearance, and that
are actually marketed in Europe are eligible for bidding.
2. General references
2.1. International guidance
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“Manufacturer” means any natural or legal person 1 with responsibility for design and/or manufacture of a medical
device with the intention of making the medical device available for use, under his name; whether or not such a
medical device is designed and/or manufactured by that person himself or on his behalf by another person(s) – GHTF-
SG1-n055-definition of terms
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2.3. Compliance with regulatory requirements
Medical devices proposed to UNFPA for procurement and supply must be from manufacturers who
are legally registered to manufacture the particular device by their national regulatory authority and
have valid manufacturing licenses.
Any official clearance or legal certificates, (e.g. 510k/PMA clearance, CE certificates, or equivalent
licences shall be provided, where applicable).
The manufacturer of the product shall provide evidence that their quality management systems
conform to the current version, at the time of the submission to the following quality management
system international standards (or local – national transcription of these standard)
In the case where a significant part of the production processes is subcontracted by the
legal manufacturer to a contractor (for example, the final sterilization, final assembly, sub
part manufacturing, etc.), then the requirement for an independent QMS also applies to
the contract manufacturer(s).
The standards to which the device is claimed to be compliant to should be part of a list of local
recognized standards (e.g. EC list of harmonized standard, as published on the OJCE, FDA recognized
standards, etc.). Proof of conformity to product specific standards shall be provided for the product
category covering the products (and product codes) to be supplied.
The sterilization plant (the manufacturer itself or any contract sterilizer company) that performs
this task shall be covered by a valid ISO 13485 certificate for the specific sterilization process:
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3.2.2. Individual sterilization batch certificates
During bid evaluation, UNFPA requires copies of certificates of sterilization from the last 3 most
recently released batches from the manufacturer.
Note: The individual batch sterilization certificate must be issued by the legal manufacturer, who
owns the entire responsibility of the compliance of the finished device.
During the procurement phase, certificates of sterilization for each batch procured by UNFPA shall
be provided to the pre-shipment inspector for each Purchase Order.
Primary packaging shall be by unit of use and secondary packaging shall provide protection of the
packaged individual units in a box.
NOTE UNFPA and other UN agencies will from 2014 going forward require that all paper
and cardboard secondary packing is FSC marked. Similarly, UNFPA will gradually between
2014-2020 increase its requirement for the use of recycled material in secondary packing.
Plastic used in secondary packing will gradually be required to be fully biodegradable.
Labelling shall meet, at least, the requirements described in the Global Harmonization Task Force
document: GHTF/SG1/N70:2011: Label and instruction for Use for Medical Devices. The language
should be in English or Spanish or French as specified.
Labelling on the medical device itself (if on medical device itself it should be in a format that will not
be dislodged during cleaning, disinfecting or sterilization of the device) or on the primary packaging
of each unit or on the primary packaging of multiple devices should contain the following where
applicable:
Name and/or trademark of the manufacturer including the full address of the manufacturer. Name
and address of Authorised Representative or Distributor maybe added but this additional label should
not obscure any of the manufacturer’s labels.
Manufacturer's product name with additional reference number or product code.
Type of product and main characteristics, i.e. details to identify the device and its use.
If the packaging is not transparent, it must bear a diagram (preferably actual size) showing the
essential parts of the product and indicating the position of the product in the packaging.
Lot number prefixed by the word "LOT" (or equivalent harmonised symbol, if applicable)/batch code
or serial number. Manufacture date should be additionally indicated.
For products supplied sterile or for single use disposable devices, the label should clearly state
STERILE and/or DISPOSABLE or SINGLE USE (or equivalent harmonised symbols). Additionally, a date
of expiry is to be stated with clear indication to expiry year and month before which the device is
considered to be safe to use. In order to verify the stated shelf life, the date of manufacture must be
included in the label. Label should include the used sterilization method where applicable.
Information for particular storage conditions that apply (temperature, pressure, light, humidity, etc.,
as appropriate must read in the package (or equivalent harmonised symbols).
Information for handling (e.g. warnings) or instructions for use, if applicable (or equivalent
harmonised symbols).
For devices that have CE marking approval, the CE mark should be on the item itself, or on the
primary packaging as appropriate. Please note: if on device itself, this should not be removable
during handling, use or cleaning of the device.
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Technical Requirements for Medical devices - CE / FDA v3: 09/10/2018
3.4. Shelf life
The shelf life of the device shall be clearly indicated. Devices with less than 75% shelf life will not be
accepted by UNFPA.
For sterile products, expiration date should not exceed 5 years from date of sterilization.
Instructions for use or manuals must be provided in the following languages or as specified: English,
Spanish or French, as per request based on recipient country of distribution. This should include any
assembly instructions.
In addition to installation details, information should be provided on service, repair and spares where
applicable. Any special tools or test equipment required should also be specified at both bid stage
and Purchase Order stage.
For equipment where training is required before competent technical staff can use the device, this
should be clearly indicated at the bid stage and also at Purchase Order stage with information of
who will provide this training.
3.6.3. Warranty
The available voltage and plug types should be specified and if contracted, the correct voltage and
plug type should be supplied for the respective country of destination as per Purchase Order.
Where appropriate, the necessary information shall be provided for the safe disposal or
decommissioning of the device after its recommended time of use. Note: some specific regulation
may locally apply.
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Manufactures will – over time - be requested to provide proof of ISO 14001 (Environmental
Standard) and ISO 50001 (Energy Standard) certification. It is therefore encouraged, but not required
before 2015-16, to have these certifications in place.
Special Note:
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